Overview
- 17 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-03.
At a glance
Inspections
17
Form 483s
10
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Apr 2024 – 3 May 2024 | Biologics | 483 | View 483 → |
| 27 Aug 2019 – 12 Sep 2019 | Biologics | 483 | On file |
| 28 Jan 2019 – 31 Jan 2019 | Biologics | Clean | |
| 14 Aug 2017 – 24 Aug 2017 | Biologics | 483 | On file |
| 20 Jun 2016 – 24 Jun 2016 | Biologics | 483 | On file |
| 14 Oct 2015 – 20 Oct 2015 | Biologics | 483 | On file |
| 25 Aug 2014 – 28 Aug 2014 | Biologics | 483 | On file |
| 26 Sep 2012 | Not recorded | 483 | On file |
| 22 Nov 2010 | Not recorded | 483 | On file |
| 12 Dec 2008 | Not recorded | 483 | On file |
| 14 Mar 2008 | Not recorded | 483 | On file |
| 17 Nov 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
3 May 2024
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Shafiq Ahadi, Gene D Arcy, Peng Zhou
3 May 2024
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Shafiq Ahadi, Gene D Arcy, Peng Zhou
Investigators
FDA investigators tied to this site in the record.
Gene D Arcy3 insp.
Deborah M Trout2 insp.
Prabhu P Raju2 insp.
Helen B Ricalde2 insp.
Shafiq Ahadi1 insp.
Peng Zhou1 insp.
Omotunde O Osunsanmi1 insp.
Decarlos A Gomez1 insp.
Vijaya L Simhadri1 insp.
Malgorzata G Norton1 insp.
Olga Simakova1 insp.
Nobuko H Katagiri1 insp.
Scott T Ballard1 insp.
Richard H Coats1 insp.
Jacqueline M Diaz Albert1 insp.
Mihaly S Ligmond1 insp.
Raymond W Brullo1 insp.
Nancy T Waites1 insp.
Joseph George1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Grifols Biologicals LLC's 10 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat